Registration Dossier

Administrative data

Description of key information

Skin irritation (OECD 404): not irritating

Eye irritation (OECD 405): highly irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

To cover the endpoint irritation of substance C9-11AE (CAS 68439-46-3), studies from similar substances were taken for a weight-of-evidence approach. Read-across is justified because the length of the alkyl chain does not exert any meaningful influence on irritation potential, whereas the degree of ethoxylation is of more importance. The irritation potential of AEs is decreasing with increasing ethoxylation degree. The lower ethoxylation level of EO 1 - 3, which includes all read-across substances, appeared to be more irritating (HERA, 2009).

 

For the endpoint skin irritation, the read-across substances C10-16 AE (CAS 68002-97-1), C6-12AE (CAS 68439-45-2) and C10AE (CAS 26183-52-8) were used to cover this endpoint.

The first study for the weight of evidence approach assessed the irritating potential to the skin with C10-16 AE (CAS 68002-97-1) according to OECD Guideline 404 and GLP. Six New Zealand White rabbits were exposed for 4 hours to 0.5 mL test substance under semiocclusive conditions and observed for subsequent 21 days. Mean erythema and oedema scores over all animals within three days were 0.8 and 0.4, respectively. Even though the effects persisted within the observation period, they are not increasing, but rather point to a slower recovery and with scores of 1 or 2. Additionally, the gross pathology does not present thickening, ulcer, superficial blistering, hyperkeratosis or flaking during healing. Hence, the effects seen are closer to a mild irritant than one with a clear R38. Due to the fact that all other tested members of this category do not show a skin irritating potential under the correct test conditions, these effects do not justify the classification R38 / Skin Irrit. Cat.2.

The second GLP-study with C6-12AE (CAS 68439-45-2) was performed in six New Zealand White rabbits which were exposed for 4 hours to the test substance under semiocclusive conditions, according to OECD Guideline 404. Mean erythema and oedema scores over all animals within three days were 0.6 and 0.3, respectively and were fully reversible within the observation period of 14 days.

The last skin irritation study was conducted with C10AE (CAS 26183-52-8) according to OECD Guideline 404 and GLP. Like in the before mentioned studies the erythema and oedema scores over all animals within three days were very low (0.2 and 0.0, respectively) and furthermore fully reversible within 48 h. No signs of toxicity were noted.

 

For eye irritation, no structure-activity relationship has been observed. Undiluted products induced response from non-irritating to severely irritating (HERA, 2009). From eye irritation study data submitted to CESIO (CESIO recommendations for Anionic and Non-ionic surfactants, May 2006), classification with R41 is recommended. Hence, even apart from available experimental results, AE are classified with R41.

As supporting data a study assessing the irritating potential to the eyes with C12-14AE (CAS 68439-50-9) according to OECD Guideline 405 was taken. Only one rabbit was treated with 0.1 mL test substance since strong reactions on the eyes were expected. The test substance revealed moderate effects on the cornea which were not reversible within 21 days. The iridal effects persisted for 17 days whereas the conjunctival reactions observed were moderate and persisted for longer than 21 days.

Effects on eye irritation: highly irritating

Justification for classification or non-classification

According to the classification criteria of Directive 67/548/EEC and Regulation (EC) No 1272/2008 the test substance needs to be classified with Xi, R41 and Eye Dam.1, H318, respectively.

No classification is necessary according to both laws for skin irritation or corrosion.